Z-2738-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- October 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1033
Product Description
Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
Reason for Recall
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Distribution Pattern
Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
Code Information
Serial Numbers Affected: V133PF2502 through V142PF3819 and manufactured between May 12, 2020 and May 21, 2020